Baxter Receives EMEA Marketing Authorization for Celvapan H1N1 Pandemic Influenza Vaccine

Baxter International Inc. (Deerfield, IL) has been granted marketing authorization for Celvapan H1N1 pandemic vaccine using Baxter’s Vero cell technology by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

Celvapan H1N1 is the first cell culture-based and non-adjuvanted vaccine to receive marketing authorization in the European Union. Initial quantities of vaccine have already been delivered to several countries, including the UK and Ireland, for use in their national vaccination programs.

Baxter is confirming the safety and immunogenicity of Celvapan H1N1 in clinical trials. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5μg and 3.75μg.

The current dosing schedule, as specified in the EMEA mock-up licensure for Celvapan using another virus strain, calls for two 7.5 μg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for Celvapan H1N1. This study also will determine whether a lower dose, 3.75μg, is sufficient to induce the necessary immune response.